First, the submission content and format requirements are the same. There are still 20 sections, and you use the same templates for either type of submission. At least a dozen forms are identical:
1. User fee (FDA Form 3601)
2. Table of contents
3. Cover sheet (FDA Form 3514)
4. Cover letter
5. Confidentiality certification
6. Indications for use (FDA Form 3881)
7. 510(k) summary
8. Truthful and accuracy statement
9. Class III summary
10. Financial certification
11. Declaration of conformity (FDA Form 3654)
12. Executive Summary
The differences between the two types of 510(k) submissions are also very predictable. The most significant difference is related to section 20--clinical performance testing. For a medical device, typically this section is not applicable. Only 10-15% of 510(k) submissions typically include a human clinical study. However, IVD products require clinical studies for 100% of submissions. IVD studies are different, because the study involves specimens--not human subjects. The specimen might be saliva, blood or plasma; but you still need clinical data to demonstrate efficacy of your diagnostic test.
There are specific questions in 510(k) RTA checklists for IVD products as well--regardless of which type of 510(k) submission you are working on. If you are making changes to an existing in IVD product, there are also specific questions in the FDA guidance documents for IVD products to help you determine if a 510(k) submission is required for your device modification.
If you are interested in learning more about IVD 510(k) submissions, there will be a webinar this Friday at 10am EDT: http://medicaldeviceacademy.com/ivd-510k-webinar/.
You can also watch the free webinar on 510(k) submissions in general that was hosted by Joe Hage: http://www.medicaldevicesgroup.net/webinar/510k-tips/.
The challenges of getting innovative medical device products out to market are subject to major regulatory audits that take a lot of time and money for the manufacturers. With software being a medical device in its own right when it falls under the definition of a medical device, the medical device software developers have to adhere to the same regulatory requirements as large medical devices do. This means FDA approval for companies placing their products to market in the USA and CE mark for the EU. The path to approval is both time-consuming as well as costly with the average of 77% of a medical device budget required for regulatory compliance in the US. With the majority of innovation stemming from small firms, the ability to maintain the competitive position and to produce technologies to address the needs of patients is put at risk.
By the time that all the required standards are implemented in and regulatory audits are passed by a medical device company, the competition for innovative medical software products might already have increased and the window of opportunity might be closing quickly. It takes more than half a year to implement one standard alone on the path to compliance.
Question for discussin: There is no doubt that the manufacturer has breached the local act and should be punished for that. But what about validity of the clinical evidence?
a) Do you think that the original clinical data (assuming that scientifically and ethically correct) is not valid?
b) Do you think that other clinical data obtained during PMCF is also not valid?
c) Is there any precedent in EU, how competent authorities are solving such issues?
Thanks for your ideas. I believe that someone may have experience with such manufacturer`s fault to share for interesting discussion within the group :-)
Does anyone know what is the meaning of "no additional cost" in COMMISSION REGULATION (EU) No 207/2012?
Is it including phone bill which make manufacturer should have free-toll number in each country?
can someone share how you deal with electronic IFU?
Medical devices can be purely hardware based (eg stethoscopes), be composed of hardware and software (eg patient monitor) or purely software (eg mobile medical apps).
In both the US and the EU, standalone software, such as a mobile app, can be a medical device in its own right if it has a medical purpose. This software may operate on a general purpose platform such as a smartphone and typically falls under the jurisdiction of a medical device regulatory authority. Such software is generally called Software as a Medical Device or SaMD.
1. What is Software as a Medical Device (SaMD)?
Software as a medical device (SaMD) is software that’s intended to be used for a medical purpose and that performs this function without being part of a hardware medical device, i.e. it runs on general purpose (non-medical purpose) computing platforms. For example, mobile apps that meet this definition are considered SaMD.
2. How do you determine if your software is a medical device?
This can vary depending on the country of sale, but in most jurisdictions (US, EU), the software is a medical device if the manufacturer (the person who legally markets the product) intends it to be used for a medically related purpose.
In other words, your software is a medical device when its intended use falls under the definition of a medical device.
The intended use is reflected in the specifications, instructions and information provided by the device (software) manufacturer.
Why You Should Hire For Potential, Not Experience
When you're hiring, look past the experience candidates come with, to the potential for them to grow into the perfect fit for your company.
What's the content of your DoCs?
According to the EU Official Journal published in 2008, the required content are:
"1. No xxxxxx (unique identification of the product):
2.Name and address of the manufacturer and/or his authorised representative:
3.This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
4.Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):
5.The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: ………
6.References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:
7.Where applicable, the notified body ... (name, number)… performed … (description of intervention) … and issued the certificate: ….
Signed for and on behalf of: ………………………….
(place and date of issue)
(name, function) (signature)"
I'm particular interested in knowing whether or not one can avoid Point 6 "References to the relevant harmonized standards used or references....."?
In my relatively short career within RA, I've never seen a DoC that contains a list of harmonized standards as this would require too much maintenance. The DoC format that i'm used to only contains references to applied Directives/Regulations and so far none of the notified bodies involved have commented this.
What's your experience?
Additionally, the recommendation emphazises that not just manufacturers but also suppliers need to be put under scrutiny. But I have not heard of this "second level" auditing process.
Can anyone in the group recommend reliable sources of information, or share any data on this topic?
Does anyone have any advice? Where should the "baseline" be set? Is there a formulaic answer?
This becomes a struggle between the pessimists of Quality and the defensiveness of Design. (I've been both, so I try to sympathize...)
I typically recommend submitting a pre-submission request before you have a “design freeze,” but I haven’t thought much about the question, “When is too early?”
Typically I am struggling to get everything complete before a 510(k) submission. However, for pre-submission meetings everything does not need to be complete. In fact, you can continue to submit additional updates to documentation after the FDA receives the pre-submission meeting request. As long as the FDA receives the documentation at least 2 weeks before the meeting the FDA will review your information.
To answer the question of when is too early, I pulled up the diagram of the design control process that I use for training courses. The diagram shows a stage-gate development process, but it also indicates when the risk management activities should be scheduled relative to design activities. I started to redraw the diagram so it was larger, and then I added the various milestones of the 510(k) process. Working backwards...
The 510(k) clearance occurs at the very end of the design process and that’s when the DHF is “closed.”
The 510(k) submission occurs at the end of design verification and validation--assuming you have been preparing the submission in parallel with V&V testing.
The 510(k) preparation begins just after V&V testing begins, because it typically takes about 14 weeks to complete the testing and the 510(k) can easily be prepared in parallel with V&V testing if you devote about 4 hours a week to the preparation.
The pre-sub meeting should take place before the approval of the design outputs (i.e., “design freeze”).
The pre-sub meeting request should be submitted 75-90 days before the target date for your meeting with the FDA. On my diagram that date is approximately around the same time that design inputs are reviewed and approved.
After seeing when the approximate time of the pre-sub meeting request submission, I realized that you can’t really submit a pre-sub request until you have identified the critical design inputs. Therefore, once you have performed a preliminary hazard identification and developed a testing plan, you should be able to review and approve you design inputs. This is really the earliest point for asking the FDA questions.
You also have to keep in mind that the FDAs answers might force to change you design inputs.
If you are interested in receiving a copy of the diagram I described above, please send me an email request at firstname.lastname@example.org. If you are already subscribed to my 510k-tips email list, you should already have an email with this diagram included. You might also be interested in my new blog about how to determine if you can submit an abbreviated 510(k) to save 30 days from your next submission: https://fdaecopy.com/abbreviated-510k/.
3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation
3D medtech printing conference maastricht presentation discussing 3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation
COMPANY ON $4B SPENDING SPREE
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With the changing face of education in many sectors to online education courses I wonder how many people or companies are changing or are thinking of changing to this form of education.
In 2015 online education was a 105 billion dollar market which is predicted to grow to 244 billion dollars by 2022.
What are the advantages of online education?
- You determine when and where to study the courses. No travelling to training centres or paying for trainers to come to you.
- Immediate results and feedback throughout the course.
- In many cases, this results in a more effective learning experience.
- Courses usually come a lot cheaper than standard classroom delivered courses.
- Courses can be tailored to specific industry needs.
But are the courses which you require available?
Yes, there are many providers of this type of education, certainly for regulatory affairs and ISO standards. However, when it comes to education for those medical device manufacturers using ERP systems I do not see ERP courses readily available. They are provided by either external or internal generic courses in most cases.
This where I would like to ask for your help.
I would like to see what the demand for this type of course would be in the medical industry for manufacturers using Oracle eBusiness Suite (EBS) R12, in particular, but not limited to, quality results data collection using the Quality module.
Could I please ask you to answer three simple questions, yes or no. Obviously any other comments you may care to offer would be welcome.
1. Does your company use Oracle EBS R12?
2. If yes, do they use the Quality module or would they consider using it?
3. If an online education for "Quality Data Collection using Oracle EBS R12 Specifcally for the Medical Devices Industry" was available, would you be interested in taking the course?
Thanks in advance for your assistance in this short survey.
The latest update is that manufacturers will be responsible for updating the Eudamed database in the future as part of the new European Regulations. This requirement will be implemented during the next years. The database will also become accessible to the public.
The primary publicly accessible database for adverse event reporting is the US FDA MAUDE database:
The MAUDE database is also integrated with other FDA databases for 510k submissions and recalls. This combined database is called the Total Product Life Cycle database:
The Therapeutic Good Administration (TGA) in Australia makes adverse event data publicly available:
The TGA also has a national registry for implanted orthopedic devices that publishes an annual report. There are other countries that also have public registries.
Searching for post-market surveillance data should be performed on a frequency that is risk-based. If you have a brand new device, a high risk device or a device that is implanted; post-market surveillance data should be reviewed frequently--either monthly or quarterly. In fact, the new European guidance document for clinical evaluation reports (MEDDEV 2.7/1 rev 4) requires that clinical evaluation reports be updated at least annually for these devices:
It is also important that you collect post-market surveillance data for both your device and competitor products. Therefore, you should be reviewing all the publicly available adverse event databases. You should also be reviewing your own complaint data, and you should be searching for journal articles that may include adverse event data--possibly associated with a clinical study.
If you are interested in the full text of this article and future articles, please visit my blog page:
Quantities? Parameters ? Forms ? How many batches ?
My current procedure template has the following sections:
1. A header with document title, document control number, revision, effective date and the author
4. References & Relationships
5. Document Approval
6. Revision History
7. Responsibilities and Authorities
9. Monitoring & Measurement
10. Training / Retraining
11. Risk Management
13. Flow Charts
Most companies include definitions, but I find that there are inconsistencies between procedures for the same term. Therefore, I place definitions in a glossary that is a standalone controlled document.
The risk management section was added to facilitate a risk-based approach to all procedures, and the monitoring and measurement section helps to identify quality objectives for each process.
However, many of my clients want to make changes to flow charts and have trouble maintaining them. Therefore, I’m thinking of removing them from procedures altogether. What do you think?
I was thinking of including flow charts that are helpful in explaining a process in training documentation only. The biggest advantage of removing the flowcharts from the procedures is that it simplifies the procedure. Procedures will be shorter and require fewer updates to prevent inconsistencies.
This change reduced the length of my training procedure by 3 pages. Other revisions shortened the overall procedure down to a final length of 4 pages, and the original version was 8 pages long.
Do you have any procedure enhancements to suggest?
If you are interested in reading more about the changes I made, please visit my blog: http://www.medicaldeviceacademy.com/blog.
Please visit my new website this Thursday to see another blog posting: https://www.fdaecopy.com/.
The third and fourth revisions of the guidance both have a 5-stage process for clinical evaluations, but in the third revision only articulated stages 1 through 3 as stages leading up to writing a clinical evaluation report. The figure in section 6.3 of revision 4 now identifies a planning Stage 0 and the writing of the clinical evaluation report is referred to as Stage 4. Therefore, there is a lot more detail describing the planning and report writing stages than there was in revision 3. In addition, Stage 2 (Appraisal of clinical data) has been expanded from a single page to eight pages.
There is also much more guidance and more examples provided in the appendices, while the 12-page clinical evaluation checklist that was provided in revision 3 has been replaced by one page of bulleted items for Notified Bodies to consider.
It is no longer sufficient to list several devices that are similar to your device and include those devices in your search of clinical literature. Now you may only select one device for equivalence. You must also provide a thorough analysis of equivalence with that device on the basis of clinical, technical and biological characteristics. This comparison includes providing drawings or pictures to compare the size, shape and elements of contact with the body.
The frequency of updating your clinical evaluations must be justified and documented. Devices with significant risks (e.g., implants) require at least annual updates to the clinical evaluation report. For devices with non-significant risks, 2-5 years is the range of possible frequency.
There are seven steps that need to be included in your quality plan for compliance with MEDDEV 2.7/1 rev 4:
1. update your external standards to replace MEDDEV 2.7/1 rev 3 with MEDDEV 2.7/1 rev 4
2. revise your procedure and associated templates for a literature review and clinical evaluation report to meet the requirements of MEDDEV 2.7/1 rev 4
3. document the qualifications of evaluators for clinical evaluations
4. document a plan/schedule for updating your clinical evaluation reports for each product family
5. train evaluators, regulatory personnel and any applicable internal auditors on the requirements of MEDDEV 2.7/1 rev 4 and updated procedures and forms
6. begin updating clinical evaluations according to your plan
7. perform an internal audit of your clinical evaluation process
If you are interested in learning more about this revised guidance document, the full-length article can be found on my blog page: http://www.medicaldeviceacademy.com/blog/.
I am also teaching a live webinar on Friday, January 27 @ Noon EST specific to MEDDEV 2.7/1 rev 4: http://www.medicaldeviceacademy.com/clinical-evaluation-procedure/.
On page 19 of the attached RTA checklist you see that question 32 has a comment about your electrical safety testing. You performed testing to IEC 60601-1, because that is electrical safety standard for medical devices. However, the reviewer is asking for a justification for why you did not test your device to IEC 60601-1-11:2015.
You learn that the -1-11 collateral standard is specific to home use devices.like yours. You need to repeat testing to the new standard or provide a justification for not doing this testing. How much will this cost? Why didn’t the UL testing lab mention this?
The most important part of new product development is to ensure that you properly identified the required design inputs. Inputs include the electrical safety, EMC and performance testing standards that are applicable to your type of device. Special controls guidance documents might have been written in 2007 and the standards are probably out of date.
Experienced regulatory professionals create a regulatory pathway analysis first to make sure all the inputs are properly identified. The regulatory pathway analysis has to be systematic and thorough. It’s too easy to miss one standard and delay 510(k) clearance by months.
You can reduce risk by requesting an FDA pre-sub meeting before you begin your testing. However, you need to request this 75-90 days prior to your “design freeze.”
About 50% of the time I find there is no special controls guidance document specific to a device, but there are a number of predicates. Key information needed is the technological details of the device, such as: material, power source, mode of operation and design features.
First you identify the product classification. I wrote a blog on this topic:
Sometimes the product classification does not include a special controls guidance document and predicates listed for the product classification are 5+ years old. Relying upon a review of 510(k) summaries is not enough. Are there other generic guidance documents specific to the technology your device uses?
Are any of the standards listed for safety and performance testing of predicates in the process of being revised?
Sometimes standards are already revised, but the FDA might not recognize the standard until several years after its release. A competitor may reference an older standard that is now superseded by a new version.
Once you have an RTA hold letter, you need to figure out what the current standards are for testing and understand how you missed the standard mentioned by the FDA reviewer. Maybe there is a scientific rationale why you don’t need this new one. Once you are 100% confident you have the right answer, I recommend that you contact the FDA reviewer and explain your planned response to the question. You want the FDA reviewer to provide some feedback so that you don’t make this mistake again. Sometimes the FDA may insist upon a pre-sub meeting to answer this question, but it’s always worth an email or phone call to the reviewer.
Good luck with your submissions in 2017. I’ll be wishing for your inbox to be full of acceptance letters instead of RTA hold letters.
Happy New Year!
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For this second case, the medical device, if classified on its own, would be a Class I, 510(k) exempt product. I understand that kitting it or making it combination product would throw it into a different regulatory category. However, the client is wondering if there is a way to “submit” the medical device separately (ahead of the combination submission) to receive FDA clearance for the medical device as a standalone product, and then just reference the clearance (510(k) number) in the drug application. Specifically, the client would like FDA to view documentation and data about the device ahead of the drug submission because they do not want the same thing to happen as before where questions about the device cause issues. The challenge in this case is the device being a 510(k) exempt product code as a standalone device.
Because this device would be 510(k) exempt, I have the following questions.
1. Would FDA accept a 510(k) submission for a product code that doesn’t require a 510(k), or would they just reject it because it goes beyond what is required?
2. I’ve been told that if you submit a Device Master File to FDA, they will not review it until it is reference in a submission. Is this true? This could be another path; but if FDA would not review it head of the drug submission, it does not meet the client’s desires.
3. Are there any other regulatory options that you are aware of for this case?
What are your views on the topic of e cigarettes will they be classed as a medical device?
I keen to hear thoughts.
How to Increase Chances of NIH SBIR Grants 333%?
Rapid Prototyping at Google X I recently attended a rapid prototyping workshop led by Tom Chi, a founding member of Google X, during the 2016 Mentor
What position should this "Responsible Person" have in the company, RRAA or it can belong to other areas? What is your experience about it?
The new draft guidance document includes modified decision trees to help manufacturers decide which types of changes will require a new submission, but there are also examples provided in Appendix A. The most helpful part of the guidance, however, is Appendix B. Appendix B explains how to document changes properly—regardless of whether a change requires a submission or not.
Typically adding a colorant, or changing a colorant, does not negatively impact strength of a device but this is the first cautionary statement made at the beginning of the section for material changes. Sometimes large concentrations of colorant result in weakening of plastics. Therefore, repeating some of the performance testing or providing data that supports the need for no further testing is expected. In the decision trees performance is addressed by question C5, “Could the change affect performance specifications?” If no, then you document the change but a new 510k is not required. If yes, then you refer to decision tree question B5.
The next concern addressed by Decision Tree C is the biocompatibility of your modified device. If the material change of the device or device component comes into direct contact with the body, blood or tissues then biocompatibility risks must be assessed. If the change does create new or increased issues related to biocompatibility then question C4.1 asks, “Has the manufacturer used the same material in a similar legally marketed device?” If the changed material has not been used previously for a similar application, then a new 510k is required—typically a Special 510k if only the material is changed and only biocompatibility needs to be assessed by the FDA.
Within the guidance document, the FDA explains that you may want to refer to “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’” (insert link) when you are answering question C4. This new final guidance was released on June 16, 2016 and the Office of Device Evaluation (ODE) appears to be focusing much more closely on biocompatibility since this new guidance released.
If you have other questions about biocompatibility or 510k submissions, on December 1 @ 11am EST I will be hosting a new live webinar on the topic of biocompatibility. The webinar will address both requirements for 510k submissions and for CE Marking technical files. If you are interested in registering for that webinar, please click on the following link:
You might also be interested in our 510k course series (Special Price of $1,200…):
You gain access to 24 webinars related to 510k submissions, the new 510(k) book and 510(k) templates.
Recently I read a procedure that states that, since regular lots size are too big, sampling can be conducted to validate the process. This is the first time I see this approach and I am kind of confused since per my understanding when process validation is conducted the regular lots must be built and 100% inspected according with the reliability/confidence level sample size drawn from pFMEA or available risk assessment. For instance 298 units if 99% R and 95% CL is required, it does not matter if the lots are a little bigger, all units must be inspected, same situation for variable data.
Is it ok to execute a validation by determing a sample size due to big lot size e.g, 2000 units? What about the cost/time?
I hope sales of these drugs was already going down before these new rules.
The US government is finally telling people that homeopathy is a sham
Companies that make homeopathic products will be required to spell out that their products are not based on science.
Least favorite was the 360 wheeled car (not actually an invention because they have not reduced it to practice, and was probably in Popular Mechanics 50 years ago).
Haven't these guys heard of CRISPR?
The 25 Best Inventions of 2016
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Chinese FDA to Update the Medical Device Classification Catalogue
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For Europe, companies are required to update their technical documentation and retest when appropriate. If they don’t retest, then a justification for the acceptability of the existing data must be provided. Unfortunately, what your Notified Body auditor will accept today might not be accepted tomorrow.
If you have CE Marking and you are planning a 510(k) submission you need to know if your rationale is sufficient. The most conservative answer is to simply retest to the newest standard. Ultimately you may have to do this anyway. However, retesting and waiting for the results takes time and money.
Another option is to submit a pre-submission request to the FDA and ask the question. In this case, probably requesting an email response will result in the most information from the FDA. If you elect for a teleconference or a face-to-face meeting you are limited to one hour of time to get feedback. If you elect for an email response, the participants providing feedback can each compile their response in the one hour and the combined input will be greater than a group meeting would provide. This approach is also free. The only cost is waiting for the response. I recommend this approach, because there are often unanticipated delays that affect submissions. You typically have a response from the FDA before you are ready to submit.
Option number three is to review previous 510(k) submissions that are available through the new Redacted FOIA 510k database. These are full 510ks that you can download from the FDA website for FREE in seconds. I have already downloaded a couple hundred as part of my own research efforts. Check out my new webinar: http://medicaldeviceacademy.com/redacted-foia-510k-webinar/. I also posted a new blog on the topic today: http://medicaldeviceacademy.com/redacted-510k/.
A fourth option is to consult with someone that has submitted a 510(k) previously for a similar device. If you review previous 510(k) summaries, you will be able to find several consultants that have significant experience with the type of device you are working on. They may have encountered a similar situation and they may have suggestions for the wording of your rationale or identify better ways to get the data you need for your submission.
Sometimes you don’t even need the data you thought you needed. Therefore, it’s always a great idea to ask testing labs and other consultants for advice—in addition to considering a pre-submission meeting request.
Finally, remember that your goal is regulatory clearance—not a
I have four new webinars to announce this week:
1. 510(k) Cover Letter & FDA Form 3514 – I recorded this short webinar Sunday and I will email templates with the slide deck and the recording. The cost is $29. The webinar is available for download at: http://medicaldeviceacademy.com/510k-cover-letter/.
2. 510(k) Boilerplate – This webinar was recorded yesterday (Tuesday morning). This webinar is FREE if you submit a question: http://medicaldeviceacademy.com/510k-boilerplate/.
3. 510(k) Declaration of Conformity & FDA Form 3654 – This is planned for next Thursday, November 17. The cost is $49. Here’s the link: http://medicaldeviceacademy.com/FDA-Form-3654/.
4. Redacted FOIA 510k Webinar – This webinar is planned for Monday, November 21. The cost is $79. There is also a new blog about this new FDA database. Here’s the link: http://medicaldeviceacademy.com/redacted-foia-510k-webinar/.
There are new webinars every week, so don’t forget to visit: http://medicaldeviceacademy.com/webinars/.
Periodontal inflammation (Periodontitis or gum disease) and chronic diseases such as diabetes and cardiovascular disease are thought to have a strong connection. (Ref: American Academy of Periodontology www.Perio.org).
So diagnosis via an oral swab test at the dentist could help to alert the patient and their doctor to preventative possibilities early enough to slow or stop serious systemic disease progression.
Do you think that we (consumers of healthcare ) are ready for genetic testing and all that comes with it? Am I alone in wondering why the dentist and the Medical Doctor do not work more in an interdisciplinary manner to improve preventative care?
In the US, the medical device industry heavily relies on a sales force covering territory to introduce a new device. Is the same true for developing nations?
Is the cost of the sales and distribution in developing nations prohibitively expensive even for devices with known demand? Excluding development costs, do major device OEMs have a business motivation to produce these products if the lower COGS targets could be achieved?
I would love to hear from anyone with experience around sales/distribution in developing nations!
ISO 9001- 13485
FDA CFR Part 820
CMDCP (Certified Manufacturing Device Compliance Professional)
GMPCP (Current Good Manufacturing Certified Professional)
GMP ICH Q7
GAMP (Good Automated Manufacturing Practice).
I would greatly appreciate any advice, please, on how to approach/prioritize this opportunity.
Thank you again,
Liam Brady MBA PMP